Clinical Trial to Evaluate the Model SC9 IOL Compared to the Model LI61SE IOL (Bausch & Lomb)

CORD, LLC

Status

Terminated

Conditions

Cataract

Treatments

Device: Model LI61SE

Device: Model SC9

Study type

Interventional

Funder types

Industry

Identifiers

NCT03179397

SC9-0015

Details and patient eligibility

About

To evaluate the Model SC9 Intraocular Lens for the improvement of near and intermediate vision when compared to a legally marketed monofocal IOL.

Full description

Subjects will be randomized to one of two groups. Group A, (Test Lens, Model SC9) or Group B, (Control Lens, Model LI61SE, Bausch and Lomb).

Both groups will be randomized to receive either unilateral or bilateral implantation. No bilateral implantation is allowed in Phase 1. (50 subjects).

Subjects will be followed for 36 Months.

Enrollment

338 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Twenty-two years or older at the time of surgery and diagnosed with bilateral cataracts
Able to comprehend and sign a statement of informed consent
Willing and able to complete all required postoperative visits
Calculated Lens Power within the available range for the study IOL's
Planned cataract removal by phacoemulsification
Potential postoperative visual acuity of BCDVA 0.2 LogMAR (20/32) or better in both eyes
Subjects with less than 1.0D of corneal astigmatism
Clear intraocular media other than cataract in the study eye
Preoperative BCDVA worse than 0.2 LogMar (20/32) with or without glare
Pupil size greater or equal to 6.0mm after dilation

Exclusion criteria

Any corneal abnormality, other than regular corneal astigmatism
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 LogMAR (20/32)
Previous refractive surgery
Amblyopia
Clinical severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
Diabetic retinopathy
Extremely shallow anterior chamber, not due to swollen cataract
Microphthalmos
Previous retinal detachment
Previous corneal surgery
Recurrent severe anterior or posterior segment inflammation of unknown etiology
Rubella or traumatic cataract
Iris Neovascularization
Glaucoma (uncontrolled or controlled with medication)
Aniridia
Optic nerve atrophy
Damaged incomplete zonules
Systemic disease that could increase the operative risk or confound the outcome
Medications that, in the opinion of the investigator may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax) or other medications with similar side-effects (floppy iris syndrome)